K192045 is an FDA 510(k) clearance for the Ophthalmic Yag Laser System YC-200. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on November 15, 2019, 107 days after receiving the submission on July 31, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K192045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF — Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |